Autosomal Dominant Polycystic KidneyNCT04907799
Daily Caloric Restriction in ADPKD
A study testing Daily caloric restriction in people with Autosomal Dominant Polycystic Kidney and Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This clinical trial will determine whether a daily-caloric restriction-based weight loss intervention can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat by magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney, Overweight and Obesity
- What is being tested?
- Daily caloric restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- ADPKD diagnosis based on the modified Pei-Ravine criteria
- Body-mass index of 25-45 kg/m^2
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73m^2
- Total kidney volume (htTKV) \> 600 mL, calculated/estimated from a previous kidney ultrasound or magnetic resonance imaging
- Access to the internet with video chat capabilities
Show all 9Show fewer
- No plans for extended travel (\>2 weeks) without internet access during the 12-month intensive period
- Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study
- Ability to provide informed consent
Who cannot join
- Diabetes mellitus
- Current smokers or history of smoking in the past 12 months
- Alcohol dependence or abuse
- History of hospitalization or major surgery within the last 3 months
- Untreated dyslipidemia
- Uncontrolled hypertension
Show all 16Show fewer
- Pregnancy, lactation, or unwillingness to use adequate birth control
- Cardiovascular disease, peripheral vascular disease, or symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, syncope
- Abnormal resting electrocardiogram (ECG): serious arrhythmias, including multifocal premature ventricular contractions (PVC\'s), frequent PVC\'s (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC\'s), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects
- Significant pulmonary disease including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
- Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism unless weight stable
- History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
- Weight loss of \>5% in the past 3 months for any reason except post-partum weight loss; weight gain \>5% requires assessment by PI
- Major psychiatric disorder (e.g., psychosis, schizophrenia, mania, bipolar disorder) or current severe depression, based on DSM-IV-TR criteria for Major Depressive Episode, which in the opinion of the Study MD would interfere with ability to adhere to dietary interventions)
- Inability to cooperate with or clinical contraindication for magnetic resonance imaging, including: severe claustrophobia, implants, devices, or non-removable body piercings
- Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \> 1 year before screening, (2) lap banding if the band has been removed \> 1 year before screening, (3) intragastric balloon if the balloon has been removed \> 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \> 1 year before screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Daily Caloric Restriction in Overweight and Obese Adults With ADPKD
This clinical trial will determine whether a daily-caloric restriction-based weight loss intervention can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat by magnetic resonance imaging. Blood and fat samples will provide insight into biological changes that may contribute to any observed benefits of the intervention.
Read the detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled renal cysts that ultimately result in renal failure. Similar to the general population, the prevalence of overweight and obesity have been rising in ADPKD patients, effecting about two-thirds of individuals. Adipocytes do not simply act as a fat reservoir, but are active endocrine organs that promote release of pro-inflammatory cytokines, and thus, may be a promising clinical target for ADPKD management. Mounting evidence also suggests that a metabolic defect exists in ADPKD, which likely contributes to cystic epithelial proliferation and subsequent cyst growth. Additionally, the investigators recently reported that overweight and obesity are strong independent predictors of more rapid kidney growth. Collectively, these data suggest that interventions to reduce abdominal adiposity may slow ADPKD progression.
Initial results from the investigators' R03-funded pilot and feasibility study support that a 12-month daily caloric restriction (DCR)-based behavioral weight loss intervention in adults with ADPKD and overweight or obesity: 1) is feasible and acceptable; 2) slowed kidney growth (annual %∆ in height-adjusted TKV [htTKV]), which was highly correlated with weight loss; 3) reduced abdominal adiposity; and 4) altered pathways implicated in ADPKD progression and metabolism. These initial results suggest that a DCR-based behavioral weight loss intervention offers a promising strategy to slow ADPKD progression. However, the pilot and feasibility study was limited by a small sample size, relatively short duration, and lack of a control group. Thus, to translate these promising results of the pilot study towards clinical practice, the investigators are conducting a randomized, controlled clinical trial in a larger number of adults with ADPKD and overweight or obesity to directly compare the efficacy of a DCR-based behavioral weight loss intervention compared to control for slowing kidney growth (primary outcome) over a longer duration. Changes in abdominal adiposity will serve as a secondary outcome and effects of weight loss on circulating and adipose markers of biological pathways will provide mechanistic insight.
In a subset of participants recruited for this clinical trial, we will measure change in kidney oxidative metabolism, insulin sensitivity, plasma metabolomics, and gut microbiota. These additional measures will aim to compare kidney oxidative metabolism, insulin sensitivity, plasma metabolome and gut microbiota at baseline and 2 years. In addition, the investigators aim to define the relations among changes in kidney oxidative metabolism, insulin sensitivity, plasma metabolome, gut microbiota, total kidney volume, and body weight over 2 years. Currently, it is unknown if weight loss via DCR modifies renal energy expenditure, substrate utilization, plasma metabolomics, or the gut microbiome.
- Being tested
- Daily caloric restriction, Standard advice control
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily caloric restrictionBehavioural
Weight loss based on daily caloric restriction and increased physical activity
Standard advice controlOther
Initial nutrition consultation without subsequent counseling
| Study group | Role | What they receive |
|---|---|---|
| Daily Caloric Restriction | Experimental | The daily caloric restriction group will participate in a 2-year, group-based, behavioral weight loss intervention based on a 30% reduction in caloric intake and increased physical activity. Receives: Behavioral: Daily caloric restriction |
| Standard Advice Control | Other | The standard advice control group will receive an initial consultation with a registered dietician regarding current clinical recommendations for ADPKD without subsequent counseling sessions. Receives: Other: Standard advice control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height-Adjusted Total kidney volume
To assess kidney growth, we will measure height-adjusted total kidney volume by magnetic resonance imaging at baseline and 24 months to determine annual percent change.
Measured: Baseline, 24-months
Secondary outcomes (16)
Change in abdominal adiposity
Abdominal adiposity (subcutaneous, visceral, and total) will be assessed by magnetic resonance imaging.
Measured: Baseline, 24-months
Change in the ratio of insulin-like growth factor-1 (IGF-1)/ to GF binding protein-1
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 12-months, 24-months
Change in adiponectin (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 12-months, 24-months
Change in leptin (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 12-months, 24-months
Change in interleukin-6 (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 12-months, 24-months
Change in tumor necrosis factor-alpha (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 12-months, 24-months
Change in C-reactive protein (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Measured: Baseline, 12-months, 24-months
Change in peripheral blood mononuclear cell protein expression of pAMPK/AMPK
PBMCs will be isolated from whole blood to assess protein expression
Measured: Baseline, 12-months, 24-months
Change in peripheral blood mononuclear cell protein expression of pS6K/S6K
PBMCs will be isolated from whole blood to assess protein expression
Measured: Baseline, 12-months, 24-months
Change in adiponectin (adipose tissue)
A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker.
Measured: Baseline, 24-months
Change in leptin (adipose tissue)
A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker.
Measured: Baseline, 24-months
Change in interleukin-6 (adipose tissue)
A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker.
Measured: Baseline, 24-months
Change in tumor necrosis factor-alpha (adipose tissue)
A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker.
Measured: Baseline, 24-months
Change in renal oxygen consumption
Renal oxygen consumption will be assessed by a PET/CT scan using 11-C acetate in a sub-set of participants
Measured: Baseline, 24-months
Change in gut microbiota
16S rRNA gene sequencing will be used for taxonomic characterization of the gut microbiota in a subset of participants.
Measured: Baseline, 24-months
Change in plasma metabolome
Untargeted plasma metabolomics will be performed using high-performance liquid chromatography-tandem mass spectrometry in a subset of participants.
Measured: Baseline, 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start3 Nov 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic KidneyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Nowak, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907799
- Sponsor's protocol ID
- 21-2999
- Other IDs
- R01DK129259
- Status last verified
- Aug 2025
- First submitted
- 25 May 2021
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
PubMed 41385299Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print.
PubMed 41348481Nowak KL, Copeland TP, Ku E, Sarnak MJ, Gitomer B, Abebe KZ, Chapman A, Perrone R, Rahbari-Oskoui FF, Steinman T, Yu ASL, Chonchol M. Overweight Status, Obesity, and Progression to ESKD in Patients with Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):520-528. doi: 10.2215/CJN.0000000640. Epub 2025 Feb 19.
PubMed 39970002Chebib FT, Nowak KL, Chonchol MB, Bing K, Ghanem A, Rahbari-Oskoui FF, Dahl NK, Mrug M. Polycystic Kidney Disease Diet: What is Known and What is Safe. Clin J Am Soc Nephrol. 2024 May 1;19(5):664-682. doi: 10.2215/CJN.0000000000000326. Epub 2023 Sep 20.
PubMed 37729939
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Caloric Restriction in Overweight and Obese Adults With ADPKD
- ClinicalTrials.gov ID
- NCT04907799
- Acronym / sponsor ID
- 21-2999
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will determine whether a daily-caloric restriction-based weight loss intervention can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat by magnetic resonance imaging. Blood and fat samples will provide insight into biological changes that may contribute to any observed benefits of the intervention.
Detailed description
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled renal cysts that ultimately result in renal failure. Similar to the general population, the prevalence of overweight and obesity have been rising in ADPKD patients, effecting about two-thirds of individuals. Adipocytes do not simply act as a fat reservoir, but are active endocrine organs that promote release of pro-inflammatory cytokines, and thus, may be a promising clinical target for ADPKD management. Mounting evidence also suggests that a metabolic defect exists in ADPKD, which likely contributes to cystic epithelial proliferation and subsequent cyst growth. Additionally, the investigators recently reported that overweight and obesity are strong independent predictors of more rapid kidney growth. Collectively, these data suggest that interventions to reduce abdominal adiposity may slow ADPKD progression.
Initial results from the investigators' R03-funded pilot and feasibility study support that a 12-month daily caloric restriction (DCR)-based behavioral weight loss intervention in adults with ADPKD and overweight or obesity: 1) is feasible and acceptable; 2) slowed kidney growth (annual %∆ in height-adjusted TKV [htTKV]), which was highly correlated with weight loss; 3) reduced abdominal adiposity; and 4) altered pathways implicated in ADPKD progression and metabolism. These initial results suggest that a DCR-based behavioral weight loss intervention offers a promising strategy to slow ADPKD progression. However, the pilot and feasibility study was limited by a small sample size, relatively short duration, and lack of a control group. Thus, to translate these promising results of the pilot study towards clinical practice, the investigators are conducting a randomized, controlled clinical trial in a larger number of adults with ADPKD and overweight or obesity to directly compare the efficacy of a DCR-based behavioral weight loss intervention compared to control for slowing kidney growth (primary outcome) over a longer duration. Changes in abdominal adiposity will serve as a secondary outcome and effects of weight loss on circulating and adipose markers of biological pathways will provide mechanistic insight.
In a subset of participants recruited for this clinical trial, we will measure change in kidney oxidative metabolism, insulin sensitivity, plasma metabolomics, and gut microbiota. These additional measures will aim to compare kidney oxidative metabolism, insulin sensitivity, plasma metabolome and gut microbiota at baseline and 2 years. In addition, the investigators aim to define the relations among changes in kidney oxidative metabolism, insulin sensitivity, plasma metabolome, gut microbiota, total kidney volume, and body weight over 2 years. Currently, it is unknown if weight loss via DCR modifies renal energy expenditure, substrate utilization, plasma metabolomics, or the gut microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Caloric Restriction | Experimental | Behavioral: Daily caloric restrictionThe daily caloric restriction group will participate in a 2-year, group-based, behavioral weight loss intervention based on a 30% reduction in caloric intake and increased physical activity. |
| Standard Advice Control | Other | Other: Standard advice controlThe standard advice control group will receive an initial consultation with a registered dietician regarding current clinical recommendations for ADPKD without subsequent counseling sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-65 years of age
- ADPKD diagnosis based on the modified Pei-Ravine criteria
- Body-mass index of 25-45 kg/m^2
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73m^2
- Total kidney volume (htTKV) \> 600 mL, calculated/estimated from a previous kidney ultrasound or magnetic resonance imaging
Key exclusion criteria (16 listed)
- Diabetes mellitus
- Current smokers or history of smoking in the past 12 months
- Alcohol dependence or abuse
- History of hospitalization or major surgery within the last 3 months
- Untreated dyslipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily caloric restrictionWeight loss based on daily caloric restriction and increased physical activity | Behavioural | Daily Caloric Restriction |
| Standard advice controlInitial nutrition consultation without subsequent counseling | Other | Standard Advice Control |
Primary outcome
Change in height-Adjusted Total kidney volume
Time frame: Baseline, 24-months
To assess kidney growth, we will measure height-adjusted total kidney volume by magnetic resonance imaging at baseline and 24 months to determine annual percent change.
16 secondary outcomes
Change in abdominal adiposity
Time frame: Baseline, 24-months
Change in the ratio of insulin-like growth factor-1 (IGF-1)/ to GF binding protein-1
Time frame: Baseline, 12-months, 24-months
Change in adiponectin (circulating)
Time frame: Baseline, 12-months, 24-months
Change in leptin (circulating)
Time frame: Baseline, 12-months, 24-months
Change in interleukin-6 (circulating)
Time frame: Baseline, 12-months, 24-months
Change in tumor necrosis factor-alpha (circulating)
Time frame: Baseline, 12-months, 24-months
Change in C-reactive protein (circulating)
Time frame: Baseline, 12-months, 24-months
Change in peripheral blood mononuclear cell protein expression of pAMPK/AMPK
Time frame: Baseline, 12-months, 24-months
Change in peripheral blood mononuclear cell protein expression of pS6K/S6K
Time frame: Baseline, 12-months, 24-months
Change in adiponectin (adipose tissue)
Time frame: Baseline, 24-months
Change in leptin (adipose tissue)
Time frame: Baseline, 24-months
Change in interleukin-6 (adipose tissue)
Time frame: Baseline, 24-months
Change in tumor necrosis factor-alpha (adipose tissue)
Time frame: Baseline, 24-months
Change in renal oxygen consumption
Time frame: Baseline, 24-months
Change in gut microbiota
Time frame: Baseline, 24-months
Change in plasma metabolome
Time frame: Baseline, 24-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 41385299Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12.
- Derived from this study: PubMed 41348481Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print.
- Derived from this study: PubMed 39970002Nowak KL, Copeland TP, Ku E, Sarnak MJ, Gitomer B, Abebe KZ, Chapman A, Perrone R, Rahbari-Oskoui FF, Steinman T, Yu ASL, Chonchol M. Overweight Status, Obesity, and Progression to ESKD in Patients with Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):520-528. doi: 10.2215/CJN.0000000640. Epub 2025 Feb 19.
- Derived from this study: PubMed 37729939Chebib FT, Nowak KL, Chonchol MB, Bing K, Ghanem A, Rahbari-Oskoui FF, Dahl NK, Mrug M. Polycystic Kidney Disease Diet: What is Known and What is Safe. Clin J Am Soc Nephrol. 2024 May 1;19(5):664-682. doi: 10.2215/CJN.0000000000000326. Epub 2023 Sep 20.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Nowak, PhD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily caloric restriction in people with Autosomal Dominant Polycystic Kidney and Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in height-Adjusted Total kidney volume (time frame: Baseline, 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04907799, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.